Negative Pressure Wound Therapy: Are All Systems Alike?

Phase 3

Terminated

Brief Summary: Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare) will be less than or equal to VAC system, (6) Patients will report less pain during dressing changes with Versatile One (EZCare).

Detailed Description: This is a prospective, 2 group, randomized, comparative study (sample:50; 25 in each group) that will investigate whether differences can be found in selected outcomes related to wound care, using Versatile One (EZCare)versus KCI VAC negative pressure/vacuum systems. Only wounds which currently meet criteria for such device use,and for which a physician's order has been written for the device, will be included in this study.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Comatose
Mentally obtunded
Documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function
Presence of Manufacturer's contraindications
Malignancy in wound
Untreated osteomyelitis
Unexplored fistula
Necrotic tissue
Exposed blood vessels or organs
Untreated malnutrition.

Arm && Interventions

Group	Intervention	Description
1	KCI -VAC	KCI VAC type negative pressure wound therapy device
2	Versatile One (EZCare)	Versatile One (EZCare) negative wound therapy device

Primary Outcome Measures

Name	Time	Method
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling	first dressing change; typically within 48 hours	differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler

Secondary Outcome Measures

Name	Time	Method
Ease of Performing Dressing Change	during hospital stay; generally 6 days	responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do
Ease of Providing Nursing Care	during hospital stay; generally 6 days	nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem
Cost of Wound Care	during hospital stay; generally 6 days	cost of device/supplies used in application and dressing changes
Nursing Time	hospital stay; generally 6 days
Patient Reported Pain	at first dressing change; generally 48 hours	scale of 0= no pain to 10= worst pain possible